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United States · US · US:42571-103_34e9a6b6-450b-7d20-e063-6294a90ac831

Glimepiride

Orange BookUNIISPLATC A10BB12

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeA10BB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4257110301
    100 TABLET in 1 BOTTLE (42571-103-01)
  • ndc11
    4257110305
    500 TABLET in 1 BOTTLE (42571-103-05)

Annotations

UNII (FDA Substance ID)
6KY687524K
GLIMEPIRIDE
RxCUI 25789
Orange Book
A091220
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6KY687524K",
    "rxcui": "25789",
    "inchikey": "WIGIZIANZCJQQY-RUCARUNLSA-N",
    "display_name": "GLIMEPIRIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9e863f84-d6f2-4d61-8250-774569e84353": {
      "match": "brand_token",
      "title": "GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "12",
      "published_date": "2026-05-21"
    }
  },
  "productid": "42571-103_34e9a6b6-450b-7d20-e063-6294a90ac831",
  "productndc": "42571-103",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091220",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jun 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Jun 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Jun 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "004",
        "approval_date": "Jun 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "6MG",
        "product_no": "005",
        "approval_date": "Jun 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "006",
        "approval_date": "Jun 29, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIMEPIRIDE",
  "proprietary_name": "Glimepiride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091220",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glimepiride",
  "start_marketing_date": "20130613",
  "active_numerator_strength": "4"
}

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